Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT01111110
• Collaborator: Children's Miracle Network (Other)
• Enrollment: 88
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

Delivery of HFA albuterol through an antistatic valved holding chamber (VHC) will improve bronchodilator response during nocturnal bronchospasm.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Device: anti-static then static; Device: Static then anti-static chamber	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anti-static then Static for Albuterol albuterol anti-static first then static chamber second.	Device: anti-static then static; Albuterol using static chambers
Experimental: Static then Anti-static for Albuterol static then antistatic albuterol	Device: Static then anti-static chamber; albuterol with Static then anti-static chambers

Outcome Measures

Primary Outcome Measures

1. Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. [fifteen minutes after 1 puff of albuterol]

   (Percent improvement in FEV1 (Forced Expiratory Volume and Forced Vital Capacity) Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 1 Puff go into chamber

2. Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. [15 minutes after 2 puffs of albuterol]

   (Percent improvement in FEV1(Forced Expiratory Volume and Forced Vital Capacity) Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 2 Puffs go into chamber

3. Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. [fifteen minutes after 4 puffs of albuterol]

   (Percent improvement in FEV1 (Forced Expiratory Volume and Forced Vital Capacity) Post Dose for Period 2 over 4AM Baseline value)less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 4 Puffs go into chamber

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18-65 years.

• Physician diagnosis of asthma.

• FEV1 60-80% predicted during the day.

• FEV1 increases ≥ 12 % and to ≥ 80% predicted after 2- 4 puffs of albuterol HFA MDI delivered by antistatic VHC.

• No smoking in the previous year and < 10-pack year history.

• No history of severe asthma attacks requiring ER visit or hospitalization in the previous three months.

Exclusion Criteria:

• Patient required a short course of oral steroid in the past 30 days.

• Any disease that is inadequately controlled or any medication that would worsen asthma or interact with asthma medications.

• History of viral respiratory tract infection in the 3 weeks prior to the screening visit.

• Positive pregnancy test.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

• University of Florida
• Children's Miracle Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01111110
• Other Study ID Numbers: IRB 103-2008; Children's Miracle Network UFl
• First Posted: Apr 27, 2010
• Last Update Posted: Feb 28, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Bronchial Spasm

Study Results

Participant Flow

Recruitment Details	Recruitment process was done in the Asthma Research Lab. Note that 88 were screened and 4 subjects randomized but determined to be ineligile before starting treatment. They are amongst the screen failures.
Pre-assignment Detail	Subjects qualified in the screening visit went into a 7 day run-in-period They needed to have a 20% peak flow overnight drop on 3/7 nights in order to qualify for overnight stays in the Clinical Research Center. Arms are identified by order of treatment assignment. Any other designation is not consistent with our protocol requirements.

Arm/Group Title	Anti-static/Static	Static/Antistatic
Arm/Group Description	albuterol with anti-static chamber then Static on another night	albuterol with static chamber then with antistatic chamber on another night.
Period Title: Overall Study
STARTED	3	4
COMPLETED	3	4
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Anti-static/Static	Static/Antistatic	Total
Arm/Group Description	albuterol with anti-static chamber then Static on another night	albuterol with static chamber then with antistatic chamber on another night.	Total of all reporting groups
Overall Participants	3	4	7
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 100%	4 100%	7 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.3 (11.1)	21.5 (2.8)	24.4 (7.2)
Sex: Female, Male (Count of Participants)
Female	1 33.3%	3 75%	4 57.1%
Male	2 66.7%	1 25%	3 42.9%
Region of Enrollment (participants) [Number]
United States	3 100%	4 100%	7 100%

Outcome Measures

1. Primary Outcome

Title	Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
Description	(Percent improvement in FEV1 (Forced Expiratory Volume and Forced Vital Capacity) Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 1 Puff go into chamber
Time Frame	fifteen minutes after 1 puff of albuterol

Outcome Measure Data

Analysis Population Description

Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.

Arm/Group Title	Anti-static/Static	Static/Antistatic
Arm/Group Description	albuterol with anti-static chamber then Static on another night	albuterol with static chamber then with antistatic chamber on another night.
Measure Participants	3	4
Mean (Standard Error) [percentage of change from 4AM]	-15.4 (12.2)	26.7 (20.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anti-static/Static, Static/Antistatic
	Comments	(Comparison of period 2 minus period 1) results Point and interval estimates are halved because this estimates twice the effect size.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.026
	Comments
	Method	t-test, 2 sided
	Comments	two sample effect size must be halved to account for mean difference estimates twice the effect size
Method of Estimation	Estimation Parameter	half the mean difference
	Estimated Value	21.0
	Confidence Interval	(2-Sided) 95%; 3.8 to 41.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.7
	Estimation Comments	See 4 Puff result

2. Primary Outcome

Title	Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
Description	(Percent improvement in FEV1(Forced Expiratory Volume and Forced Vital Capacity) Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 2 Puffs go into chamber
Time Frame	15 minutes after 2 puffs of albuterol

Outcome Measure Data

Analysis Population Description

Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.

Arm/Group Title	Anti-static/Static	Static/Antistatic
Arm/Group Description	albuterol with anti-static chamber then Static on another night	albuterol with static chamber then with antistatic chamber on another night.
Measure Participants	3	4
Mean (Standard Deviation) [percentage of change from 4AM]	-15.3 (14.1)	31.8 (19.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anti-static/Static, Static/Antistatic
	Comments	Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.018
	Comments	The effect size is half the difference between the means as (A-B)-(B-A)=2A-2B
	Method	t-test, 2 sided
	Comments	Must take half the mean difference to estimate effect size
Method of Estimation	Estimation Parameter	half the mean difference
	Estimated Value	23.5
	Confidence Interval	(2-Sided) 95%; 6.0 to 41.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.8
	Estimation Comments	No comments

3. Primary Outcome

Title	Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
Description	(Percent improvement in FEV1 (Forced Expiratory Volume and Forced Vital Capacity) Post Dose for Period 2 over 4AM Baseline value)less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 4 Puffs go into chamber
Time Frame	fifteen minutes after 4 puffs of albuterol

Outcome Measure Data

Analysis Population Description

Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.

Arm/Group Title	Anti-static/Static	Static/Antistatic
Arm/Group Description	albuterol with anti-static chamber then Static on another night	albuterol with static chamber then with antistatic chamber on another night.
Measure Participants	3	4
Mean (Standard Deviation) [percentage of change from 4AM]	-17.5 (13.6)	31.9 (19.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anti-static/Static, Static/Antistatic
	Comments	Null hypothesis is that the Treatment order is independent of the dependent variable based on Period 2 minus Period 1
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.013
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Effect size=half the mean diff
	Estimated Value	24.7
	Confidence Interval	(2-Sided) 95%; 7.7 to 41.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.6
	Estimation Comments	You kicked this out on another trial, but note that the period 2-Period 1 differences between the orderings estimate twice the effect size. The effect sizes herein take this into account.

Adverse Events

Arm/Group Title	Static		Antistatic
Arm/Group Description	albuterol with static chamber		albuterol with antistatic chamber.
All Cause Mortality
	Static		Antistatic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Static		Antistatic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Static		Antistatic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)

Limitations/Caveats

Nocturnal asthma model is a very sensitive model, but very labor intensive and to get more completed subjects, we might need to do multicenter trial

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.